Opinion By Dr. Jean Covillo, CRNA
When our choices as individuals overwhelmingly threaten the health and prosperity of our society ~ one must question whether these choices, are indeed, truly “personal.”
Every day I see, hear, and read about folks angrily defending their rights as U.S. citizens to make their own decisions, live their own way, and any number of other complaints that apply to any one of their constitutional “rights”. Although many of these arguments are valid, and worthy of debate, I rarely hear anyone add “personal responsibility” when demanding and defending those “rights”. Instead, these arguments seem to arise from a sense of personal entitlement without consideration of responsibility that accompanies these “rights.”
There are many arguments being presented as to why folks are refusing vaccinations and to a very small degree, I would agree that some of them are valid. Vaccination hesitancy is a very real issue for many and we need to do a better job of educating folks, dispelling all the ugly myths, and encouraging folks to get vaccinated. But the argument that I most want to address is the one where people use “personal rights” as a valid excuse for their decision to refuse, saying things like “it is my body, and I have the right to refuse to get this.” “I will take my chances. My choice only affects me.” “I am young and I will be fine.” Those arguments would have merit if, the consequence of this choice only affected the person making it. But it doesn’t. The consequences of refusing to get vaccinated impacts everyone. When “personal choices” and “personal rights” affect all of us, it is no longer considered a “personal choice” or a “personal right.” What about my rights to seek medical care in a hospital without fear of contracting a more virulent strain of Covid (Delta Variant)?
Several weeks ago, my husband had to go to the ER for a severe bacterial infection that had gotten into his blood. He was gravely ill and urgently needed to be seen, admitted and receive antibiotics intravenously. He did not need to be exposed to a bunch of people sick with Covid because they refused to be vaccinated. COVID infections were overloading the hospitals and the ER when we arrived and we waited hours and hours, while he shivered with fever in a non-reclining chair in an ER that was also overloaded with Covid patients I was concerned for his safety. We almost weren’t given a bed for an illness so severe, he required a week-long stay, and home antibiotic infusion therapy for six weeks following discharge! Thankfully he did not contract the Covid virus during his stay. Refusing the vaccination simply due to “personal choice” places you squarely in the center as the source of the problem and is one of the biggest reasons this country can’t get over this pandemic. This “personal choice” has a direct impact on me, my coworkers, my family, and my friends as well as everyone else breathing the same air on this beautiful planet. It prevents our economy from moving forward, leads to more hospitalizations and delays in acute care and elective surgeries. My company depends on healthy patients and staff to available to perform elective surgeries. Choosing not to get vaccinated doesn’t only affect you-it affects ALL of US in EVERY aspect of society!
Historically, laws have been made to protect society from the hazardous effects that sometimes arise through our “personal choices”. For example, cities along the coast implement mandatory evacuations when hurricanes are imminent. These laws were passed not only to protect its citizens but to protect emergency personnel from endangering themselves during unnecessary rescue procedures for citizens who refuse to leave. One might argue, these folks have a right to stay in their homes, but if their decisions threaten the safety of others, is this a “personal right?” Seat belt laws, speed limits, enforcement of road closures during icy conditions, “No Smoking” in public places, and environmental regulations associated with chemical dumping in our rivers and lakes, are just a few examples of laws passed to protect society from individuals exercising their “personal rights” in a manner that threatens others. The question we must all ask ourselves when spouting our personal rights is this: Do personal rights give us the right through our choices to threaten the safety of our fellow man?
The science community has provided overwhelming evidence that shows the Covid vaccinations (Pfizer and Moderna) to be incredibly safe for the individual, highly effective in reducing the severity of a COVID infection and slowing down the spread. If we can reduce the transmission, we can reduce the virus’ ability to continue to mutate and put an end to its reproduction. If we refuse to take steps to reduce the transmission, this virus will mutate again which ultimately will result in a variant unresponsive to vaccines on the market-and yes-that affects me too! Please Trust the Science and the Doctors and Nurses in your community. Ask them…don’t look for answers by friends on Facebook. In fact, don’t even look to me. This is not a political decision. Listen to your doctor-Get vaccinated- and help us end this nightmare!
People simply must be educated on how the personal choice to refuse the vaccine is simply not one that can be personally made. Everyone who can get vaccinated simply must. Please encourage your friends to get vaccinated. If we are unsuccessful in quickly doing this on our own steam voluntarily, then other measures must be implemented to protect the health, safety, and economic prosperity of society from the few unwilling to see beyond themselves.
By Jean Covillo, DNAP, MA, CRNA
March 27, 2021
Until Medicaid expansion actually takes effect, non-disabled adults without children are not eligible for Medicaid in Missouri (MO HealthNet) regardless of how low their income is, and parents with dependent children are only eligible with incomes that don’t exceed 22 percent of the poverty level. Do you know what 22% of the federal poverty level (FPL) is? For those without a calculator handy, I’ll do the math for you: Anyone making less than $2,833.60/year for a single person. Since Missouri only allows households with dependents to qualify, a family of 2 must make less than $3,832.40/ year or $319/Month in order to be eligible for Medicaid. Only Texas and Alabama have lower Medicaid eligibility caps, at 18 percent.
Republican lawmakers blocked Medicaid expansion funding from reaching the Missouri House floor on Thursday, posing a setback for the voter-approved plan to increase eligibility for the state health care program.The House Budget Committee voted along party lines not to pass a bill allowing Missouri to spend $130 million in state funds and $1.6 billion in federal money to pay for the program’s expansion. Under the Affordable Care Act, the federal government picks up 90% of the tab on expanding Medicaid. Republicans sited cost as one of the biggest reasons for the obstruction. Let’s take a closer look at this flawed rationale.
In 2021, the national average unsubsidized premium for a 40-year-old non-smoking individual purchasing coverage through the Marketplace was $436 per month for the lowest-cost silver plan and $328 per month for a bronze plan, which equates to nearly eighty percent of income for those at the lower income range of people in the gap (below 41% FPL) and nearly a third of income for those at the higher income range of people in the gap. My opinion?…Get real! No one can be expected to use 80% of their paycheck to pay for health insurance regardless of how much money is earned, let alone a salary this low.
Missouri citizens rightly recognized this for what it is: A serious health crisis. In August of 2020 Missourians did the right thing by joining 38 other states that had voted to approve Medicaid expansion. The amendment was approved by a margin of 53.2 to 46.7 percent allowing Medicaid to expand eligibility to people between the ages of 19 and 65 as long as their income is at or below 138 percent of the federal poverty level. In other words Medicaid in Missouri will now include single folks making less than $17,774.40 and families of 4 making less than $36,570. The expansion was estimated to cover 230,000 Missouri individuals and has a July 1 deadline for implementation. Sounds great right? Well …not quite. Although the amendment was approved by a majority of the voters, legislators are now refusing to fund the Program-effectively saying the voters don’t know what’s best. Without passing a bill that outlines funding, the plan cannot be expanded.
Missouri’s history of missing out on billions in federal funding
In states that expand Medicaid, the federal government paid the full cost of expansion through 2016. Starting in 2017, the states gradually started to pay a share of the expansion cost, but the states’ portion according to federal statute, would never be more than 10 percent. Because of the generous federal funding for Medicaid expansion, states like Missouri that rejected it missed out on billions of federal dollars that would otherwise have been available to provide healthcare in the state. And they are continuing to miss out on added revenues. A University of Missouri School of Medicine study in 2012 concluded that Medicaid expansion would be highly beneficial to the Missouri economy and its citizens by increasing jobs, increasing tax revenue from newly employed citizens, and increased gross state product (GSP). These increases in state revenues over the 2014-2020 years were estimated to net 1 billion dollars in revenues over expense. But Missouri legislators apparently didn’t read the report. Consequently, in June 2014, the Missouri Economic Research and Information Center announced that healthcare job growth in Missouri had slowed considerably since 2012, and was falling behind compared with states that had expanded Medicaid. Healthcare is the state’s largest employment sector.
From 2013 through 2022, Missouri was projected to give up $17.8 billion in federal funding by not expanding Medicaid. That number will end up being a little lower, however, since Medicaid expansion is or was expected to take effect at some point in 2021. Apparently now, it is not up to the voters and instead is in the capable hands of Mo legislators who think they know best.
Urban and suburban voters in Missouri largely approved the Medicaid expansion, as did nearly a third of the rural voters. Without the roughly 102,000 rural voters who supported the amendment in August 2020, the Amendment would have failed. However, Republican state Representative Sara Walsh cited the amendment’s low support among rural voters as a reason to oppose its funding. State Representative Ed Lewis said that opposing the bill also makes sense considering that the 53.2 percent of voters who approved the expansion don’t amount to a majority of either the state’s eligible voters or its population. If that’s the argument why would these same votes be considered a majority for winning legislative candidates? I don’t follow the logic..do you?
What happens if Missouri legislators refuse to fund the Program?
Missouri’s Medicaid program does not currently cover most adults without children. Only the disabled, children and parents with incomes under 18% of federal poverty level — less than $5,800 a year for a family of four — are eligible. It is one of the lowest eligibility thresholds in the nation. The expansion will allow adults earning up to 138% of the federal poverty level to be covered. This expands eligibility to those families of 4 to $36,570.00.
Hospitals in Missouri that treat uninsured patients have been especially hard-hit, as their federal disproportionate share hospital funding has started to be phased out (it was supposed to be replaced by Medicaid funding) and the uninsured rate has remained higher than it would have been with Medicaid expansion in place. As a result of Missouri’s decision to opt out of Medicaid expansion, hospitals in the state were projected to lose $6.8 billion between 2013 and 2022. Refusal to fund the program will force more rural hospitals to close.
The August 2020 vote was a citizen mandate in which many Republican citizens supported. Republicans enjoyed the overwhelming majority of the elected candidates which is a clear indication these voters supported the expansion amendment. As such, these Republican constituents will view their winning legislators’ opposition to the expansion as a betrayal of their vote. The COVID-19 relief bill recently signed into law contains $1.1 billion in funding specifically allocated towards expanding Medicaid. The federal funds could also help the state’s rural hospitals and healthcare industry.
What is the real reason for legislator opposition?
Although Republicans have cited the cost, many have long resisted expanding Medicaid in Missouri, likely due to the corresponding federal requirements to provide women’s health care resources such as contraception as a condition of federal funding. Across the capitol this week, a conservative effort to block Medicaid from paying for certain contraceptives has stalled approval of annual funding for the entire program. Late Tuesday night, Sen. Paul Wieland, Republican, amended a routine hospital tax bill that helps pay for Medicaid by inserting a provision that prohibits the program from covering “Any drug or device approved by the federal Food and Drug Administration that may cause the destruction of, or prevent the implantation of, an unborn child.” Some oral or implanted contraceptives could fit that description. Federal regulations require all insurance to cover contraceptives, with religious exemptions. A separate rule requires Medicaid programs to cover family planning services but does not explicitly spell out contraceptives. Missouri law already prohibits Medicaid coverage of abortion except in cases where the mother’s life is at risk.
In Missouri, Gov. Mike Parson opposed the expansion but said he would move forward with implementation after passage of the ballot question last year. It is difficult to see how he will manage that when Budget Chair, Cody Smith, Republican has been busy separating money from Parson’s proposed $34 billion state budget, signaling his intent to obstruct Medicaid funding efforts. Smith has also cut $245 million of general revenue spending from Parson’s proposed budget, including some money for new mental health centers. In the latest failed Medicaid funding bill attempt, nine Democrats voted for funding and 20 Republicans, including Smith, voted against. Missouri Secretary of State Jay Ashcroft commended Smith and committee vice chair Dirk Deaton, Republican on a Twitter post, for their “commitment to fiscal responsibility.” According to KC Star reporting, Deaton stated the following in defense of his opposition, “It is to give free health care, government health care to able-bodied adults who can do for themselves.” I would like to know who he is appealing to with this ridiculous argument: It’s certainly not the Republicans who voted for Medicaid expansion back in August of 2020.
My two cents-(for what it’s worth)
Although Medicaid expansion has been approved by Missouri voters, and Governor Parsons has expressed he would implement it-it won’t move forward without passing a bill designed to fund the program and Republicans are refusing to do it. The majority of the funding is available now through the COVID Relief bill and state budgetary allocations-if you can pry it away from Budget Chair, Rep. Cody Smith. Funding Medicaid expansion is critical for Missourians. Missourians expressed their approval when the amendment passed with Republican and Democratic support. Missouri state legislators were elected by these people and can just as easily be removed through the same process. I wonder if Representatives Sarah Walsh, Ed Lewis, Cody Smith, and Dirk Deaton will consider that the 53.2 percent of voters who could vote them out in the next election, will then amount to a majority of the state’s eligible voters or its population? We’ll have to wait and see. In the meantime, you can click on their name and send them an email if you think it will help.
Urgent Priority Initiative: Updates Needed for CRNA Modifier Codes
By Jean Covillo, DNAP, MA, APRN, CRNA
The ASA’s rationale for a dominant position in the market depends on their ability to provide evidence of improved outcomes relative to CRNAs. “This is not too difficult if the evidence collected contains ambiguously generated data from two separate and distinct provider categories.” Jean Covillo, DNAP, MA, CRNA
CRNA Professional Identity is threatened through efforts by the American Society of Anesthesiologists (ASA) to create an “alternative” reality where Anesthesia Assistants (Assistants) are proffered as the substitute equivalent to the CRNA. Examples of this include changes in the name from Anesthesia Assistants to Certified Anesthetists, …sound confusing? How about the ASA legislative efforts aimed at placing restrictions on the use of the term “anesthesiologist” or “anesthesiology” in the CRNA professional title? These efforts ignore the basic fact that the term “anesthesiology” refers to the study of anesthesia which, last I checked, was not exclusive to the practice of medicine. Regardless, the ASA believes the term to be proprietary. But, probably the most worrisome effort staged so far, that is capable of altering perception, relates to the intermixing within the Medicare modifier code, QX. QX is the code used to identify the anesthesia provider when services are administered under medical direction. This code informs Medicare that services were performed by a “qualified” non-physician provider, ie, a CRNA or an Assistant. But since both individuals share the same code-it isn’t possible to discern which provider type was involved in the service. I think the ASA prefers this ambiguity. You might be asking yourself, “Why is this happening?” and “What is the big deal?”
Why is this happening?
The ASA depends heavily on arguments of “increased safety” when making the case for the increased labor costs associated with services provided under the medical direction and supervision anesthesia delivery models. The ASA’s rationale for a dominant position in the market depends on their ability to provide evidence of improved outcomes relative to CRNAs. The easiest way to obtain “evidence” of improved outcomes relative to CRNAs is to intermix the data reported by CRNAs and Assistants without any distinction given to the provider “type.” Current medical direction modifier codes are shared between the CRNAs and Assistants. Both providers are required to identify themselves with the same modifier code when working as a member of the anesthesia care team (ACT).
Modifier Codes: Currently Anesthesiologists have 5 codes that specifically address who they are and what type of delivery model is being used while CRNAs have only 1 that is specific to their identity. The physician modifiers are as follows: 1) AA-Anesthesiologist alone, 2) QY -Anesthesiologists medically directing 1 “qualified” provider which includes both CRNAs and Anesthesia Assistants, 3) QK -Anesthesiologists medically directing 2-4 “qualified” anesthesia providers, 4) AD- Anesthesiologist supervising more than 4 concurrent procedures, and 5) GC-Anesthesiologist medically directing a physician anesthesiologist in training. CRNAs have only one modifier code that is specific to the CRNA provider; QZ, which is used by CRNAs when providing services independently without the medical direction of an anesthesiologist. CRNAs and Anesthesia Assistants both use the modifier QX when providing services under the medical direction of an Anesthesiologist. CRNAs also use the QX modifier when working under the medical supervision delivery model. When anesthesiologists provide medical direction, there is no distinction made on the claim form as to which “qualified” anesthesia provider (Assistant or CRNA) actually performed the service. Although both CRNAs and Assistants are “qualified” to provide services alongside an anesthesiologist, the similarities end there.
CRNAS are Independent Providers
CRNAs undergo extensive training and education. Most have received Master’s degrees and current CRNA educational programs now require Doctoral degrees. CRNAs are licensed to independently provide all types of anesthesia services without any oversight or interference by an anesthesiologist. CRNAs are recognized and reimbursed for independent practice by Medicare in all states at exactly the same rates as their physician counterparts. So of course, CRNAs are “qualified” to provide services with an anesthesiologist under the medical direction model just as they are “qualified” to administer anesthesia services without any anesthesiologist at all. Conversely, the Anesthesia Assistant is exactly what the name describes, an assistant whose services are ancillary to the physician anesthesiologist. Assistants are not trained to work independently, cannot bill for services without an anesthesiologist, and are not legally authorized to provide services without close supervision by an anesthesiologist.
CRNAs have a long history of safe anesthesia delivery with more than 10 well-documented peer-reviewed studies over the past twenty years which have found no difference in quality or safety when CRNAs work alone as compared to CRNAs who work alongside anesthesiologists. Conversely, the safety record of an Assistant is directly related to the degree of supervision administered by an anesthesiologist. Studies have shown failures in anesthesiologist supervision 37% of the time even when supervising two providers, let alone the 4 providers they are authorized to oversee at one time. This means that more than a third of all patients receiving anesthetics by Assistants, are undergoing lapses in coverage due to unavailability of the anesthesiologist during critical times of the procedure, and standard of care is not being met. Remember, the 37% failure rate exists when supervision ratios involve 1 physician to 2 Anesthesia Assistants. Imagine what the failure rate would be when ratios involve 1 physician to 4 Assistants.
When two completely different provider categories are intermixed in a non-discriminative fashion, the performance data is shared and cannot be easily distinguished. If these providers also shared equivalent qualifications, ie, educational certification, training, licensure, and authority to bill there would be no issue with this approach. But considering CRNAs are qualified and licensed to work independently while Assistants require strict supervision by an anesthesiologist, it is clear these providers share very little in common—hence my issue. As a CRNA, I am not OK with CRNA safety and performance measures hinging on the performance of ancillary services provided by an assistant especially when I have no control over whether these assistants received adequate physician supervision.
Proper Coding Improves Evidence in Reporting
Modifiers are created to separate provider “types” in order to identify the services and skills associated with each classification and to track performance measures by providers. These measures address safety, cost-efficiency, and quality of services. By creating a modifier specific to CRNAs, the two provider categories can be separated and compared through various reporting mechanisms. When issues arise, root cause analyses can be conducted with targeted solutions. When Assistants are involved in “failed” medical direction, due to lapses in supervision, the result and consequence is much more than a “concurrency” issue- -it is illegal for Assistants to provide services independently and doing so results in substandard care, patient safety is threatened, and the facility risks losing its licensure and accreditation. Conversely, when supervision criteria are not met when working with CRNAs and the medical direction model fails, the modifier can be changed to QZ without concomitant reductions in standard of care, and CMS will reimburse at 100% the payment.
As it stands, all documented reporting involving CRNAs and Assistants are being lumped together into the same bucket. There is no means to differentiate practice performance and safety records between these two different provider categories and other regulatory differences cannot be easily discerned. While the performance and safety records of Assistants are enhanced from the addition of CRNA data, the same cannot be said for the CRNAs, especially when more than a third of the procedures are likely to involve substandard care due to lapses in supervision when medically directing Assistants. A lumped together bucket of data will include high performance scores and excellent safety results from CRNAs and more than likely, “not” so excellent results from Assistants which taken together equals mediocrity. This is the “alternate reality” that is being presented through hard-core evidence and reports. For these reasons, CRNAs must be given a unique code that is distinctly specific to their profession when working in the ACT. This distinction will serve to insulate the CRNAs from liability relative to negative outcomes unrelated to their care. Since different regulatory rules apply to the Assistants, the modifiers used to identify each provider must differentiate between them on the billing claim so that accurate reporting mechanisms can be in place.
What’s the Big Deal?
No two types of providers with different skill-sets, licensure, and regulatory requirements should be lumped together as the same provider when practice performance measures may be used to affect payment and licensure. How would a GYN surgeon feel if they were lumped together with family practice when looking at hysterectomy complications, or perhaps a better example might include data collected without differentiation between an orthopedic spine specialist mixed together with the neurosurgeons under the same surgeon code. Or how about having the anesthesiologists and CRNA share the same codes? It is no mystery why CRNAs and Assistants are being lumped together with one modifier code. The data collected from both increases the overall performance of Assistants and lowers the overall performance of CRNAs . When taken together-you see mediocrity associated with the “non-physician” provider moniker. This provides indisputable evidence that these providers are—desperately in need of an anesthesiologist to ensure the safety of the patient. This would be funny—if it wasn’t working.
The ASA’s rationale for a dominant position in the market depends on their ability to provide evidence of improved outcomes relative to CRNAs. This is not too difficult if the evidence contains ambiguously collected performance data obtained from two separate and distinct provider categories. The ASA’s ongoing efforts to persuade the public and other regulatory authorities to view the qualifications of CRNAs and Assistants as the same, serves only one purpose. That purpose is not to improve patient safety or cost-efficiencies. Instead, these efforts ensure a dominant position in the market through the use of manipulated data as evidence supportive of improved outcomes when physicians are involved in the delivery of care.
This deceptive practice has to stop. CRNAs must take the necessary steps to ensure their practice is protected from identity theft. The first step involves working with CMS to create a new and unique modifier specific to the CRNA when providing services under the medical direction delivery model.
By Jean Covillo, DNAP, MA, CRNA
Any healthcare facility that employs Anesthesia Assistants is trapped into using ONLY the costly medical direction model!
Currently, there are approximately 54 million Medicare enrollees, but by 2030, this will rise to nearly 80 million.1 Medicare reimbursement rates for anesthesia services are 25-35% the amount received from commercial payers. Those on Medicare will need more care and increased access to quality, safe, cost-effective services. With rising numbers of Medicare beneficiaries at a significantly lower reimbursement rate, business models must adapt to a higher level of efficiency or be doomed to Darwin’s law of natural selection. Certified Registered Nurse Anesthetists (CRNAs) and Anesthesiologists (ANs) play a critical role in meeting this challenge by providing safe, efficient, quality anesthesia care at a cost that ensures access to anesthesia for millions of Americans. Each provider is independently capable of providing the same services, leaving the choice of delivery model based on preference rather than necessity. Conversely, Anesthesia Assistants (AAs) can only provide services ancillary to an AN and are unable to operate independently. This squeezes the choice of delivery models down to one option: medical direction, leaving no room for flexibility in workflow or cost-effective alternatives. Hospital administrators often don’t realize the economic significance, or financial consequence they’ll face when hiring AAs -only to discover it after it is too late.
Anesthesia Delivery Models
Four anesthesia delivery models are commonly used by U.S. healthcare facilities: 1) AN only; 2) CRNA only; 3) AN medical direction of CRNAs, or AAs; and 4) AN supervision of CRNAs. Each delivery model is associated with a specific modifier code that identifies which type of provider is involved in the anesthetic. The first two models: AN only, and CRNA only are equally recognized by Medicare at 100% of the allowable charge. The remaining two models have conditions or adjustments tied to payments, rendering them extremely inefficient and expensive with no offsetting redeemable benefit for the money spent.2,3
Despite the variety of anesthesia delivery models, CRNAs have no federal or state requirement to be supervised by, directed by, or even work with a physician anesthesiologist. CRNAs can provide non-medically directed care in all states regardless of state supervision requirements. Although some states may require CRNAs to be supervised, the operating practitioner commonly fulfills this requirement. Conversely, AAs can only provide service under the medical direction model.2,3 Healthcare facilities cannot employ an AA without also employing an AN—who, at a median compensation of $533,000, earns nearly three times more than an AA or CRNA. As previously stated, any hospital healthcare facility that employs AAs is trapped into using ONLY the costly medical direction model. Oftentimes hospital administrators don’t realize this consequence until it is too late. Alternatively, a facility can employ a CRNA as a standalone provider or rely on a mixed provider approach by hiring both CRNAs and ANs without restrictive ratio requirements. This approach results in higher numbers of CRNAs and less ANs, ensuring quality of care, increased workflow flexibility, and a more favorable bottom line.
When performing services under the medical direction model, both CRNAs and AAs are recognized by Medicare for 50% of the payment with the remainder allocated to the physician AN. However, there is a professional and economic distinction between these two providers. CRNAs are recognized in all states by Medicare for the provision of non-medically directed services and are reimbursed at 100% of the allowable amount when billing without medical direction. Conversely, AAs are not recognized by Medicare for non-medically directed services and cannot legally provide care if there is a lapse in supervision (medical direction). These “lapses” can lead to costly surgical case delays, regulatory violations, or accreditation jeopardy for facilities if lapses occur.4 Conversely, when CRNAs are involved in failed medical direction, the model can be reclassified to the CRNA only QZ model without reductions in payment.
Anesthesia Models -Value Scale Rating
Numerous studies have performed cost analyses of anesthesia delivery models. In 2016, a study was performed by The Lewin Group, entitled Update of Cost Effectiveness of Anesthesia Providers which showed the highest gross profit was found in the CRNA only model, followed by medical direction with an AN/CRNA ratio of 1:4.5 Most hospitals utilizing AAs provide medical direction services at a 1:3 and sometimes 1:2 ratio, which drastically reduces gross profit by more than $1 million dollars as shown in the table below. Increasing physicians staffing to support these types of ratios often results in higher stipends that hospitals pay to subsidize these groups to offset losses in productivity.
Table from The Lewin Group, prepared for American Association of Nurse Anesthetists.Update of Cost Effectiveness of Anesthesia Providers: Final Report Falls Church, VA: Lewin Group Inc May 2016. http://www.lewin.com/content/dam/Lewin/Resources/AANA-CEA-May2016.pdf. Accessed December 6, 2020.
The Problem with Medical Direction
In addition to being one of the most inefficient and costly delivery models, medical direction exposes facilities to fraud and other regulatory infractions that can threaten accreditation and result in loss of licensure.4 When providing services under medical direction, completion and compliance of the TEFRA6 regulations requires strict discipline in a fluid healthcare environment. Failure to comply with these regulations can result in a fraud abuse claim. A study in 20127 performed by two ANs looking at medical direction compliance, determined there were supervision lapses 37% of the time—even with supervision ratios of 1:2. These lapses are not in compliance with billing requirements and can result in violations under the False Claims Act (FCA). ANs are not solely liable for these claims. If a CRNA or AA is aware of non-compliance or lapses in TEFRA regulations and fails to report such infractions, they can be held legally responsible and face criminal and/or civil penalties for these violations. Federal penalties can total three times the amount of the claim, plus fines of $5,500-11,000 per claim. State laws also include fines as well as imprisonment in some cases.4
Given these lapses are a fairly common occurrence and independent practice is illegal for AAs, one might contend that the liabilities associated with hiring AAs far outweigh the benefits. Regardless of the practice makeup, providers and administrators need to be aware of these billing requirements and take steps to ensure compliance.
The success in managing a cost-efficient anesthesia department that translates into millions in savings hinges on two critical components: 1) the licensure of the anesthesia staff, and 2) the elimination of medical direction delivery models. Profit margins increase when hiring practices are modified to ensure only professionals licensed and capable of flexibly working and billing autonomously. CRNAs and physician ANs are the only professionals capable of independently providing anesthesia services that are both recognized by Medicare for 100% of the Medicare allowable rate. Since AAs cannot work independently, hospitals must hire additional physicians to satisfy supervision requirements and models cannot be flexibly interchanged once the AAs are hired. Hiring Professional CRNAs or physician ANs instead of ancillary anesthesia assistant staff ensures all members can maximally contribute to the team. Concurrencies that prevent ANs from meeting medical direction criteria cannot be offset by billing the QZ model (as can be done with CRNAs), and may instead result in regulatory violations and accreditation jeopardy for facilities.8
Through adaptation and elimination of the medical direction model, hospitals running 12-24 rooms can expect to see savings between $550,000-$2,000,000, respectively. These savings are a direct result of staffing modification that removes unnecessary AN fixed-ratio requirements which will become critical as Medicare beneficiaries rise.
Medical direction models are expensive because every procedure adds the cost of two anesthesia providers when one is sufficient, when reimbursement only pays for one. In a collaborative team approach, each provider contributes services according to their licensure, training and expertise as a team. This ensures costs remain low through the use of one provider instead of two, for each procedure. In addition to lowering operating expense, this approach promotes flexibility in workflow which fosters increased productivity through its adaptability when cases are added or moved from room to room. Taken together, these benefits create opportunities for significant increases in net profitability as long as staffing is maintained by independently practicing licensed providers.
For business-minded professionals, it is easy to see why medical direction models should be eliminated. The increased cost, inefficiency of workflow, and risk of noncompliance penalties are sufficient reasons to re-evaluate the way a hospital provides and pays for anesthesia services. What healthcare facilities fail to recognize is that by hiring AAs, they are trapping themselves into using costly and inefficient medical direction models which limits all available options. The inability of AAs to practice independently forces hospitals to hire more physician ANs and removes any flexibility in adaptation toward a more fiscally sound anesthesia delivery model. Although this guarantees job security for ANs by ensuring hospitals hire sufficient quantities of their numbers, it exposes hospitals and other healthcare facilities to extreme vulnerability—both financially and regulatory—and removes all viable options by trapping them into one of the most inefficient delivery models available.
“It is not the strongest of the species that survive, or the most intelligent, but the one most responsive to change.” Charles Darwin
- Report to the Congress: Medicare and the Health Care Delivery System | June 2015. http://www.medpac.gov/docs/default-source/reports/chapter-2-the-next-generation-of-medicare-beneficiaries-june-2015-report-.pdf
- Centers for Medicare & Medicaid Services. Payment for Moderate Sedation Services. Department of Health & Human Services; 2017. Transmittal 3747. Accessed February 10, 2021. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3747CP.pdf
- Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual Chapter 12 – Physicians/Nonphysician Practitioners; see Section 50 for Anesthesiologist Services and 140 for CRNA Services. Accessed February 10, 2021. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf
- Silberman MJ, False Claims Act Liability for CRNAs Related to Medical Direction. AANA Journal. 2014; 82:10-12
- The Lewin Group prepared for American Association of Nurse Anesthetists. Update of Cost Effectiveness of Anesthesia Providers: Final Report Falls Church, VA: Lewin Group Inc May 2016. http://www.lewin.com/content/dam/Lewin/Resources/AANA-CEA-May2016.pdf. Accessed December 6, 2020.
- Tax Equity and Fiscal Responsibility Act, HR4961, 97th Congress (1981-1982). Pub L No. 97-248. Accessed January 10, 2021. https://www.congress.gov/bill/97th-congress/house-bill/4961
- Epstein RH, Dexter F: Influence of supervision ratios by anesthesiologists on first-case starts and critical portions of anesthetics. ANESTHESIOLOGY 2012; 116:683–91
- According to the Medicare Part A Conditions of Participation (which hospitals must meet in order to accept Medicare patients), an anesthesiologist assistant can only administer anesthesia when under the supervision of an anesthesiologist (42 CFR §482.52 (a) (5). For Medicare Part B payment/billing purposes, in 1992, federal law mandates that “the anesthesiologist assistant must work under the direction of an anesthesiologist …” and comply with the 7 requirements for billing medically directed anesthesia (i.e., TEFRA) (see: 57 Fed. Reg.33878, 33891, July 31, 1992 and 2 CFR §410.69 (b)(1)). In 2013 the Center for Medicare and Medicaid Services (CMS) clarified and confirmed that anesthesiologist assistants (AAs) are prohibited from billing Medicare for non-medically directed services (billing code QZ). This is in contrast to CRNAS, who are authorized to bill Medicare directly for non-medically directed services. See CMS Policy Transmittal #2716 dated May 30, 2013, available at CMS.go
Dispeling myths associated with Covid vaccine development.
Compiled by Jean Covillo, DNAP(C), CRNA
I have encountered a lot of folks who have expressed concern related to receiving these vaccines due to misinformation they have read regarding vaccine development and the erroneous belief that embryonic stem cells are used to make the vaccine. I want to assure you that both the Moderna and the Pfizer/BioNTech vaccine do not utilize embryonic material in their vaccines and neither company used these materials to create their vaccine. Here is the reality. Scientists have gained a lot of knowledge over the years from embryonic stem cell research that has led to groundbreaking discoveries on how to reprogram our own cells to “act” exactly like embryonic cells without using or relying on embryonic cells or tissue in the process. That’s right-I repeat-the cellular components and/or cells being used in this vaccine development comes from both synthetic material (man-made) or our very own cells found in our own adult bodies that have simply been reprogrammed! They did not come from embryos or fetal tissue.
Most of us don’t read articles like this and vaccine development is complicated. This information is only intended as educational and in no way represents my opinion as it relates to embryonic stem cell research. I simply want to offer information on the subject matter so that you can be armed with the facts before making a decision. I have numbered the sources and shown them in blue. Each of these blue labeled numbers are links to the original source. I hope after reading this and doing a little of your own research you decide to get vaccinated.
What are stem cells? (1)
Stem cells: The body’s master cells
Stem cells are the body’s raw materials — cells from which all other cells with specialized functions are generated. Under the right conditions in the body or a laboratory, stem cells divide to form more cells called daughter cells.
These daughter cells either become new stem cells (self-renewal) or become specialized cells (differentiation) with a more specific function, such as blood cells, brain cells, heart muscle cells or bone cells. No other cell in the body has the natural ability to generate new cell types.
Where do Stem Cells Come From?(2)
Stem Cells come from two main sources and have different capabilities to replicate. These two types are embryonic stem cells and adult stem cells.
Embryonic stem cells. The embryonic stem cells used in research today come from unused embryos. These result from an in vitro fertilization procedure. They are donated to science. These embryonic stem cells are pluripotent. This means that they can turn into any type of cell, i.e., the cell can become a liver cell, or a blood cell, or a brain cell. This versatility allows embryonic stem cells to be used to regenerate or repair diseased tissue and organs. Many people disagree on the ethical use of embryonic stem cells for research. We won’t get into that discussion here. Instead we will simply focus on the information.
Adult stem cells. There are 2 types of adult stem cells. One type comes from fully developed tissues such as the brain, skin, and bone marrow. There are only small numbers of stem cells in these tissues. Unlike embryonic stem cells, they are more likely to only be able to generate certain types of cells. For example, a stem cell that comes from the liver will only make more liver cells. They are limited by the degree of differentiation they can assume.
The second type of adult stem cell is called “induced pluripotent stem cells”. These are adult stem cells that have been modified in a lab by reprogramming them to be more like embryonic stem cells. These modified cells can then act just like embryonic stem cells and turn into any type of cell, i.e., liver cell, blood cell, brain cell. Scientists first reported that human stem cells could be changed and modified in this manner back in 2006. Induced pluripotent stem cells don’t seem to be different from embryonic stem cell. It is these adult stem cells that are being used in vaccine development and not actual embryonic stem cells.
Structure of Nucleic Acids (3)
Nucleic acids are the most important macromolecules for the continuity of life. They carry the genetic blueprint of a cell and carry instructions for the functioning of the cell.
The two main types of nucleic acids are deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). DNA is the genetic material found in all living organisms, ranging from single-celled bacteria to multicellular mammals. The other type of nucleic acid, RNA, is mostly involved in protein synthesis. The DNA molecules never leave the nucleus but instead use an intermediary to communicate with the rest of the cell. This intermediary is the messenger RNA (mRNA). In the natural world, the body relies on millions of tiny proteins to keep itself alive and healthy, and it uses mRNA to tell cells which proteins to make. If you could design your own mRNA, you could, in theory, hijack that process and create any protein you might desire — antibodies to vaccinate against infection, enzymes to reverse a rare disease, or growth agents to mend damaged heart tissue. This is the premise with which Pfizer and Moderna developed the Covid vaccine.
How mRNA Research Aided Vaccine Development (4)
Both the Pfizer and the Moderna vaccines rely on messenger RNA. If you could design your own mRNA, you could, in theory, hijack the cellular processes and create any protein you might desire — antibodies to vaccinate against infection, enzymes to reverse a rare disease, or growth agents to mend damaged heart tissue. But synthetic RNA is notoriously vulnerable to the body’s natural defenses, meaning it would likely be destroyed before reaching its target cells. And, worse, the resulting biological havoc might stir up an immune response that could make the therapy a health risk for some patients. After a decade of trial and error, two leading immunologist scientists Karikó and Weissman at BioNtech (the Pfizer vaccine), came up with a remedy for mRNA’s Achilles’ heel. The stumbling block was that injecting synthetic mRNA typically led to that troublesome immune response; the body sensed a chemical intruder and went to war. The solution, they discovered, was the biological equivalent of swapping out a tire.
Every strand of mRNA is made up of four molecular building blocks called nucleosides. But in its altered, synthetic form, one of those building blocks, like a misaligned wheel on a car, was throwing everything off by signaling the immune system. these scientists simply substituted a modified nucleoside into the synthetic MRNA strand creating a hybrid version of the mRNA that could sneak its way into cells without alerting the body’s defenses.
This discovery was written up in a few papers in 2005 which largely flew under the radar but caught the attention of two other key scientists — one in the United States, another abroad — who would later help found Moderna and Pfizer’s future partner, BioNTech. Derrick Rossi, a native of Toronto, was a 39-year-old postdoctoral fellow in stem cell biology at Stanford University in 2005 when he read the first paper. Not only did he recognize it as groundbreaking, he now says Karikó and Weissman deserve the Nobel Prize in chemistry. Rossi wondered whether modified messenger RNA might hold the key to obtaining something else researchers desperately wanted: a new source of embryonic stem cells that could be created from regular adult stem cells, which would eliminate the controversy associated with obtaining these cells from discarded embryos.
The reason embryonic stem cells are so important is that these cells have the ability to turn into any type of cell in the body, which gives them the potential to treat a dizzying array of conditions, from Parkinson’s disease to spinal cord injuries. But using those cells for research had created an ethical firestorm because they are harvested from discarded embryos. Rossie wondered if he could use this hybrid synthetic mRNA to reprogram adult stem cells into pluripotent stem cells so that they acted like embryonic stem cells. He asked a postdoctoral fellow in his lab to explore the idea. In 2009, after more than a year of work, the postdoc waved Rossi over to a microscope. Rossi peered through the lens and saw something extraordinary: a plate full of the very cells he had hoped to create through the modified mRNA process without ever using an embryonic stem cell in their production. Cloaking mRNA so it could slip into cells to produce proteins had a staggering number of applications.
After isolating the virus from patients, Chinese scientists on Jan. 10 posted online its genetic sequence. Because companies that work with messenger RNA don’t need the virus itself to create a vaccine, just a computer that tells scientists what chemicals to put together and in what order, researchers at Moderna, BioNTech, and other companies got to work.
Pfizer/Moderna Vaccine Development and Roll-out (5)
Moderna and BioNTech each designed a tiny snip of genetic code that could be deployed into cells to stimulate a coronavirus immune response. The two vaccines differ in their chemical structures, how the substances are made, and how they deliver mRNA into cells. Both vaccines require two shots a few weeks apart.
The first coronavirus vaccine to roll out was made by Pfizer and BioNTech. The approach utilizes new developments in research to protecting you from infection by using what is called messenger RNA or mRNA. Unlike a traditional vaccine, this new one relies on genetic code to stimulate an immune response against COVID-19.
The mRNA vaccine contains instructions for making the distinctive spike protein found on the surface of the coronavirus and which attaches to a particular protein in our body. Once the mRNA is inside your muscle cells, they use them to make the protein and display it on their surface, according to Pfizer. Your immune system spots the protein, recognizes it as foreign and begins to make antibodies.
Like other vaccines, the one designed to protect you from COVID-19 prompts your immune system to produce antibodies, just as if you had been exposed to the virus. How this one differs from traditional vaccines is in its use of mRNA. Instead of a weakened or an inactivated germ into your body, this vaccine injects mRNA, the genetic material that our cells read to make proteins, into your upper arm muscle.
This particular mRNA is programmed with the instructions your cells need to make a replica of the the “spike protein” found on the surface of the Corona Virus. Your body responds by making this “spike protein” on the surface of the cell which then triggers your immune system to make antibodies against the protein. Through these coded instructions the mRNA moves into your cells and teaches your body how to make the protein that triggers antibody production so if the real virus later enters your body, your immune system will recognize it, according to the federal Centers for Disease Control and Prevention.
Do the COVID-19 vaccines contain aborted fetal cells? (6)
Answer from infectious diseases expert James Lawler, MD
No, the COVID-19 vaccines do not contain any aborted fetal cells. However, Pfizer and Moderna did perform confirmation tests (to ensure the vaccines work) using fetal cell lines.
But it’s important to have the full context: Fetal cell lines are not the same as fetal tissue. Fetal cell lines are cells that grow in a laboratory. They descend from cells taken from elective abortions in the 1970s and 1980s. Those individual cells from the 1970s and 1980s have since multiplied into many new cells over the past four or five decades, creating fetal cell lines. Current fetal cell lines are thousands of generations removed from the original fetal tissue.
When it comes to the COVID-19 vaccines currently approved for emergency use, neither the Pfizer nor Moderna vaccines used fetal cell lines during the development or production phases. (So, no fetal cell lines were used to manufacture the vaccine, and they are not inside the injection you receive from your doctor.) However, both companies used the fetal cell line HEK 293 in the confirmation phase to ensure the vaccines work. All HEK 293 cells are descended from tissue taken from a 1973 elective abortion that took place in the Netherlands.
Answer from Oxford development team: According to the University of Oxford development team, the original Human Embryonic Kidney 293 cells were taken from the kidney of an aborted fetus in 1973, but the cells used now are clones of the original cells. “What’s important for the public to know even if they are opposed to the use of fetal cells for therapies, these medicines that are being made and vaccines do not contain any aspect of the cells in them,” Dr. Deepak Srivastava, president of Gladstone Institutes and former president of the International Society for Stem Cell Research, said.
The congregation repeated the Vatican’s call on pharmaceutical companies and governmental agencies to produce, approve and distribute ethically acceptable vaccines, that is, without using morally compromised cell lines at all. The doctrinal office also said that “vaccination is not, as a rule, a moral obligation and that, therefore, it must be voluntary.”From an ethical point of view, “the morality of vaccination depends not only on the duty to protect one’s own health, but also on the duty to pursue the common good,” it added. If there are no other means to stop or prevent an epidemic, the congregation said, “the common good may recommend vaccination, especially to protect the weakest and most exposed.”
Those who wish, for “reasons of conscience,” to refuse vaccines produced with cell lines from aborted fetuses, “must do their utmost to avoid, by other prophylactic means and appropriate behavior, becoming vehicles for the transmission” of the virus.
In other words, if you are choosing not to accept the vaccine out of religious principle, or moral/ethical concerns then you have an equally important moral and ethical responsibility to ensure you avail yourself of all means to prevent yourself from transmitting the virus to others. This means wearing masks, and social distancing and if concerned you may have been exposed, quarantining yourself.
They must avoid putting at risk the health of those who cannot be vaccinated for medical or other reasons and who are the most vulnerable, it said.
This material was obtained and credited to the resource links printed below and the only credit I can take for any of this information, is splicing it together in a manner that is helpful in understanding it. My recommendation is for everyone to do their own research. I just wanted to dispel the myths associated with embryonic involvement in the development stage and the notion that embryonic tissue was part of the vaccine. Neither vaccine relies on embryonic tissue or cells to be produced. Hopefully you will find this useful in making your decision.
Resources and Recommended Articles:
Tip: The cart goes behind the horse!
By Jean Covillo, DNAP (C), CRNA
Many studies exist that address salaries and other compensation benefits associated with the CRNA profession when practicing as an employee or an independent contractor.1 But no published studies exist that address CRNA-led practices that receive compensation through direct billing reimbursement. The percentage of CRNAs who directly bill “fee for service” is unknown and reimbursement benchmarks have never been established. Previous methods used to identify and differentiate this practice subset have been obscured and distorted through the widespread use of the QZ modifier. Historically the independently practicing CRNA could easily be identified by tapping into the Medicare claims databases (or other large claim databases) and separating out claims submitted with the QZ modifier, signifying the procedure was performed by a non-medically directed CRNA. Nowadays, QZ claims no longer clearly represent independently practicing CRNAs or those participating in “fee for service” billing. Instead, they may more accurately reflect the number of claims reclassified and submitted by physician-led practices that “failed medical direction”.2-5
Hospitals and surgery centers have increasingly turned to CRNAs for safe, cost-effective alternatives to traditional physician-led anesthesia delivery models. Anesthesia delivery by CRNAs is oftentimes the only viable economic option for facilities operating fewer than four rooms where case volume reimbursement is insufficient to support an anesthesiologist directing multiple CRNAs. Instead of paying stipends to make up for the increased operating expense, facilities are outsourcing the anesthesia services to CRNA groups equipped in all aspects of care, including the complexities associated with anesthesia billing.6-10 Consequently, more and more CRNA-led groups are seeking participation with commercial payers (payers) as “in-network” providers.
The commercial insurance industry is a highly competitive, profit-driven enterprise that fully relies on the longstanding practice of transactional secrecy and non-disclosure agreements when negotiating provider rates. The original intent behind these secrecy laws was to minimize exposure to “price-fixing” practices employed by large groups of providers leveraging higher payer rates. In reality, the consequence of these laws has left specific provider types like the CRNA vulnerable. By creating a system shrouded in secrecy, providers are unable to reasonably gauge the fair market value as compared to peers, leaving specific providers vulnerable to exploitation and discrimination with no means to show evidence this is occurring. Reductions in CRNA reimbursement rates based purely on licensure of the provider rather than performance and quality, unfairly disadvantages the CRNA from freely competing in the healthcare market.
In an effort to overcome these secrecy regulations, the ASA has performed yearly reimbursement rate surveys for its physician members, giving valuable insight critical for contract negotiation. CRNA-led practices do not participate in these surveys.11Consequently, the commercial rates published are only reflective of physician-led practices and offer no distinction or comparison to rates negotiated by practices led by CRNAs .
Future study will focus on correcting this deficiency through database development specific to CRNAs who contract directly with commercial payers to provide “fee for service” anesthesia delivery under the QZ modifier. Since the number of CRNAs who fit into this subset is currently unknown and no database is available that identifies CRNAs with these characteristics, a pilot study will be initiated aimed at database development. This database will formulate the population sample necessary to accurately study CRNA reimbursement while establishing reimbursement benchmarks specific to CRNAs and identifying and resolving commercial insurance policies affecting parity in payment under the QZ modifier. To participate in this project click on the link. CRNA Billing Population Database
- American Association of Nurse Anesthetists 2020 Compensation and Benefits Survey (2019 Data)
- Quraishi J, Jordan L, Hoyem R. Anesthesia Medicare Trend Analysis Shows Increased Utilization of CRNA Services. AANA Journal. 2017;85(5):375-383. doi:https://www.masscrna.com/assets/docs/qz_article.pdf
- Miller TR, Abouleish A, Halzack NM. Anesthesiologists are affiliated with many hospitals only reporting anesthesia claims using modifier QZ for Medicare claims in 2013. A&A Case Rep. 2016;6(7):217-219 DOI: 10.1213/XAA.0000000000000223
- Sun E. Does the Modifier “QZ” Accurately Reflect Independent Nurse Anesthetist Practice: And Why Does It Matter? A & A Case Reports. 2016 Apr;6(7):220-221. DOI: 10.1213/xaa.0000000000000254
- Byrd JR, Merrick SK, Stead SW. Billing for Anesthesia Services and the QZ Modififer: A Lurking Problem. ASA Monitor. 2011;75(6):36-38. https://pubs.asahq.org/monitor/article-abstract/75/6/36/4781/Billing-for-Anesthesia-Services-and-the-QZ?redirectedFrom=fulltext. Accessed Dec 4, 2020.
- Massie, MB. Determinants of Hospital Administrators’ Choice of Anesthesia Practice Model.Virginia Commonwealth University.2017; https://core.ac.uk/download/pdf/84403806.pdf. Accessed Dec.4, 2020.
- The Lewin Group, prepared for American Association of Nurse Anesthetists.Update of Cost Effectiveness of Anesthesia Providers: Final Report Falls Church, VA: Lewin Group Inc May 2016. http://www.lewin.com/content/dam/Lewin/Resources/AANA-CEA-May2016.pdf. Accessed December 6, 2020.
- O’Neill NA (2017) Anesthesia Policies- Increasing Costs with No Improvement in Value. J Healthc Commun. 2:66. doi: 10.4172/2472-1654.100107
- Quintana, J.F., Jones, T., & Baker, K. (2009). “Efficient Utilization of Anesthesia Practice Models: A Cost-Identification Analysis.” Unpublished manuscript.
- Hogan PF, Seifert RF, Moore CS, Simonson BE (2010) Cost effectiveness analysis of anesthesia providers. Nursing Economics 28: 159-169.
- Stead S, Merrick S. ASA Survey Results for Commercial Fees Paid for Anesthesia Services – 2019. ASA Monitor October 2019, Vol. 83, 70–77. https://pubs.asahq.org/monitor/article/83/10/70/108371/ASA-Survey-Results-for-Commercial-Fees-Paid-for. Downloaded December 27, 2020.
There is a growing trend towards prosecuting healthcare providers in the criminal court system for errors and mistakes. Although there are many published articles written both in support and opposition of this practice, there is a compelling argument to be made for eliminating it. Criminally prosecuting healthcare providers for medical errors in our existing environment should at least be refined or eliminated entirely. This statement is supported in part by the fact that systems errors are becoming more and more prevalent throughout the nation and through the recognition that the criminal court system is not set up or equipped to reliably judge healthcare providers fairly by using the current methods employed. Both of these reasons are more fully explained in the arguments outlined below. These arguments are followed by a brief description of an alternate solution.
Argument I. Medication Errors and the Prevalence of System Wide Failures
A 1999 report, Hendee, W.R. (2001) entitled To Err is Human by the Institute of Medicine reported that medical errors are usually the result of system wide failures. Since that report, Mitchell, I., Schuster, A., Smith, K., Pronovost, P., & Wu, A. (2015) published the National Patient Safety Forum (NPSF) report that states in part that despite some improvement in patient safety in the United States, the pace and scale of improvement has been disappointingly slow and limited and that much work is needed to be done to improve patient safety. These reports are lending credibility to the concept that many medication errors are unlikely to be attributable to a single provider. Yet single providers are being held individually responsible when criminally prosecuted.
When medical errors and mistakes happen, it is oftentimes a combination of individual and system wide failures. The question must be asked, “Did the error happen due to a failure of one individual or were there flawed processes in place that contributed or caused the failure of the individual? Examples would include technical issues with medication bar coding software, or staffing issues that forced the individual to work in an unaccustomed environment. In these instances, “was the behavior of the individual flawed or was the environment responsible for altering the behavior to create this flaw?”
A few examples of these system-wide failures are summarized by Cady, R. F. Esq., RNC, BSN, JD, CPHRM, (2009) in her journal publication entitled Criminal Prosecution for Nursing Errors. She lists two distinct cases involving criminal proceedings brought against nurses who administered medication errors leading to a patient death. Case #1 (Kowalski K, Horner M. 1998) describes an incident where three nurses with excellent qualification and experience were working in the delivery/mother/baby floor in which an order for penicillin was prescribed for a newborn. The medication was filled by the pharmacy in a concentration more than 10X the dose prescribed and when the nurses received it; she noticed only the high volume of medication (2.5 ccs) and thought this volume too high for a single IM injection. She did not consider the concentration might be wrong. So rather than give 4-5 injections IM, she and the other nurses consulted reputable outside references that showed it could be given IV. The baby arrested within three minutes of administration due to the inaccurately prepared dose.
Case #2, (Treleven E. 2006) involves a nurse who accidentally mistook one patient’s epidural IV piggyback medication for another patient’s antibiotics, which were commonly put in similar small IV bags. The administration of epidural medications by the IV route resulted in a fatal IV infusion of epidural medication. The patient seized, the baby was successfully delivered, but the mother died. This error occurred around the time the nurse was coming off two back-to back shifts and in the middle of her third, after having slept at the hospital eight hours between the second and third shift. The hospital had been desperate for help and pleaded with her to take the extra shifts, which she had. In addition to fatigue, the machine used to scan bar codes to ensure the right patient received the right drug was acting up and malfunctioning and nurse managers had openly encouraged “workarounds” until it could be fixed. Both cases involved criminal charges due to medication errors that led to a patient death. Both cases, although presenting with completely different circumstances, had many striking similarities:
- Each case was investigated by the Institute of Safe Medication Practice (ISMP) whose findings were consistent with multiple system wide errors. In fact, the ISMP found that the first case, (Kowalski K, Horner M. 1998) had more than 50 identifiable instances where medication process deficiency errors transpired across all specialty areas and included system wide involvement among specialties before the nurses made the final fatal medication error.
- Both prosecutions held the nurses out to be wholly criminally liable for the crimes without accessory involvement. Although the pharmacist was reported to the state board that performed an investigation, the pharmacist was not disciplined and was not criminally indicted.
- Each case resulted in the nurses being subjected to the authority of the board of nursing who conducted an appropriate investigation, resulting in a myriad of appropriate disciplinary actions including licensure suspension, fines, continuing education requirements, probationary periods and many others aimed at educating and deterrence of future offenses.
- Following the nursing board disciplinary action, each case was deemed appropriately handled and closed by all involved until the cases were brought forward in the media.
- Both cases involved criminal indictments for actions that the regulatory boards had already disciplined. In the first case prosecutors indicted all three nurses with the criminal charge of negligent homicide, each facing a five-year jail term if convicted and the second case, the nurse was indicted for negligence of a patient causing great bodily harm, facing 6 years imprisonment, and/or a penalty of $25,000 if convicted.
- Both cases included public statements from the state hospital associations and the boards of nursing declaring the justice system was unwarranted in criminally prosecuting the nurses for unintended errors. The prosecutions proceeded despite these public declarations.
Argument 2: The Criminal Court System is Not Set Up or Equipped to Offer Fair Judgment.
Too often the criminal court system makes a criminal charge that inherently involves “intent” such as gross negligence without fully taking into consideration whether or not “intent” was a factor in the action committed/ omitted or if the action, was an unfortunate mistake. In the recent Tennessee Case (Lallo, C., 2019) involving a nurse who had committed a medication error leading to a patient death by mistaking a paralytic medication for a sedative, the nurse has been indicted for reckless homicide, in violation of Tenn. Code Ann.§ 39-13-215, a Class D felony. The nurse was also indicted for “knowing physical abuse or gross neglect of an impaired adult in violation of Tenn. Code Ann. § 71-6-119, a Class C felony.”
Reckless Homicide is defined by Tennessee Statute as:
(a) a reckless killing of another.
(b) Reckless homicide is a Class D felony.
And the second charge of violation of: TN Code § 71-6-117 (2014) which states in part the following:
(a) It is an offense for any person to knowingly, other than by accidental means, abuse, neglect or exploit any adult within the meaning of this part.
It should be blatantly obvious to everyone; the nurse carried no intent to knowingly cause the patient harm.
The National Council of State Boards of Nursing (NCSBN) does not agree with that definition of reckless and say that, “[an error is considered “reckless” when a nurse consciously takes a “substantial or unjustifiable risk].” The NCBSN elaborates, that although these errors do substantiate disciplinary action, supervision and penalties, it is not something that should be referred for criminal prosecution unless there was a deliberate attempt or conscious intent to do harm. (Sofer, D. 2019). The distinction being made between the NCSBN and the criminal courts is twofold and shows that NCSBN believes: the definition of “reckless” includes a consciousness of action that forces a consideration of “intent” and, differing from many states’ definitions of “recklessness” which typically state that the person was either aware of the risk or any reasonable person would have been aware of the risk and chose to ignore it, and the second difference is that the determination of intent to do harm must be present before criminal prosecution can be considered. These two considerations are the two main points in which the two sides have difficulty reconciling.
Edie Brous, a nurse attorney and contributing editor for The American Journal of Nursing (AJN) (Sofer, D. 2019) believes that “reckless behavior” should always be fully investigated in order to determine whether the behavior was a ‘reckless’ workaround or a reflection of systemic errors.
“In either case, Edie Brous states, “I don’t believe a prosecutor has the requisite knowledge to understand what constitutes ‘recklessness’ in clinical practice. Practice breakdowns occur for many reasons and a just culture analysis requires a full root-cause analysis that looks at all contributing factors and distinguishes among human error, at-risk behavior, and reckless behavior.” (Sofer, D., 2019 pg. 12).
In addition to these concerns, there are also serious problems within the criminal court system when instructing a jury on how to determine whether or not the behavior of the defendant meets the definition of the crime, due to the very “vagueness” of the words describing the conditions necessary to result in the crime. Quick, O., 2011 describe this by summarizing the points made in the case R v. Misra, Srivastava  in regard to whether the elements of gross negligence manslaughter were sufficiently certain as follows,
“Vague laws which purport to create criminal liability are undesirable, and in extreme cases, where it occurs, their very vagueness may make it impossible to identify the conduct which is prohibited by a criminal sanction. If the court is forced to guess at the ingredients of a purported crime any conviction for it would be unsafe”.
There are many law publications that attempt to describe the means with which judges can administer easy to understand instructions to juries in order to help them determine whether or not the conditions of the action meet the requirements as defined in the law. If it is necessary for entire publications to be made because it is this vague, and this difficult to instruct a jury on the means of interpreting whether or not a crime has been committed, it follows that our criminal court system is not a reliable and just environment for this to be carried out.
Alternative Solution to Prosecution
Legislatively extending the jurisdiction of Nurses’ Boards to explicitly allow broad authority to investigate and render judgments for all matters pertaining to allegations of professional wrongdoing leading to severe injury or death of a patient would be a positive step towards resolving issues where nurses fall victim to inherent system errors contributing to their mistakes, (Bryant, R. 2004). If criminal proceedings are to be considered, the healthcare provider must be allowed proceedings where they are afforded a fair and just investigation of the facts. This type of investigation can only transpire if authority is given to the Board of Nursing. Due to the complex nature of the healthcare profession and a known systems wide history of medication errors across the nation in which the nurse is forced to closely interact on an ongoing basis, the criminal justice system is just not adequately set up or equipped to make these sort of life-altering judgments with any reliance the prosecution and jury will have the necessary faculties to grasp the professional vagaries encountered daily when providing healthcare services.
Bryant, R. (2004). Nursing culpability: a proposal for change in nursing regulation. J Law Med, 11(3), 341–350. doi: 10.1016/s2155-8256(17)30048-0
Cady, R. F. (2009). Criminal Prosecution for Nursing Errors. JONAs Healthcare Law, Ethics, and Regulation, 11(1), 10–16. doi: 10.1097/nhl.0b013e31819acb0d
Hendee, W. R. (2001). To Err is Human: Building a Safer Health System. Journal of Vascular and Interventional Radiology, 12(1). doi: 10.1016/s1051-0443(01)70072-3
Kowalski, K., & Horner, M. D. (1998). A Legal Nightmare. MCN, The American Journal of Maternal/Child Nursing, 23(3), 125–129. doi: 10.1097/00005721-199805000-00004
Lallo, C. (2019, February 4). https://www.newschannel5.com/news/nashville-nurse-charged-with-reckless-homicide-after-elderly-womans-death. News Channel 5. Retrieved from https://www.newschannel5.com/news/nashville-nurse-charged-with-reckless-homicide-after-elderly-womans-death
Mitchell, I., Schuster, A., Smith, K., Pronovost, P., & Wu, A. (2015). Patient safety incident reporting: a qualitative study of thoughts and perceptions of experts 15 years after ‘To Err is Human.’ BMJ Quality & Safety, 25(2), 92–99. doi: 10.1136/bmjqs-2015-004405
Sofer, D. (2019). Is a Medical Mistake an Error or a Crime? AJN, American Journal of Nursing, 119(5), 12. doi: 10.1097/01.naj.0000557895.82994.81
To Err Is Human. (1999). Science, 284(5419). doi: 10.1126/science.284.5419.1457b
Treleven E. (2006). ‘I’d give my life to bring her back,’ nurse gets probation in pregnant teen’s death. Wisconsin State Journal. December 16, 2006. This is case #2
West, J. C. (2007). Criminalization of medical errors: When is a mistake more than just a mistake¿. Journal of Healthcare Risk Management, 27(1), 25–36. doi: 10.1002/jhrm.5600270106
R v. Misra, Srivastava  EWCA Crim 2375
(a) It is an offense for any person to knowingly, other than by accidental means, abuse, neglect or exploit any adult within the meaning of this part.
TN Code § 39-13-215
What the Politicians aren’t telling you.
Written by Jean Covillo
The US healthcare system spends more dollars than any other developed country yet ranks the worst in healthcare outcomes. According to a study conducted by the Commonwealth Fund, which regularly ranks healthcare systems across the world’s 11 most developed countries, the US is also the worst performer. Not only has the US spent significantly more than other developed countries at 16.6% of GDP compared to 10% GDP for every other nation, it has done so consistently for the past twenty years all while life expectancy is continually declining. David Blumenthal, president of the Commonwealth Fund states these findings are due mainly to a lack of insurance coverage, administrative inefficiency, and under-performing primary care. 1
Although these points are valid, they do not include any discussion related to the 800-pound-gorilla-in the room, PROFIT. Profit derived from the big private insurance and pharmaceutical industries is a critical underlying root cause of the healthcare crises we face today. The money generated from these companies is used to fund political campaigns effectively shaping and influencing critical health care policy making decisions.
No good can result from a dynamic where profit holds priority over our ethical responsibility to provide societal health care and yet that is what is happening with large “for-profit” insurance and pharmaceutical companies who through their large political contributions, set the price and conditions associated with health care with little regard for the needs of the patient or that of the provider. The truth is that the costs associated with the overall healthcare “pie” are being divided up in a highly inefficient, disproportionate and frankly unethical manner with profits and administrative costs gobbling up the Lion’s share.
Aside from these profits, studies show administrative costs currently account for 30% of the total healthcare dollars spent in America. 2
This is twice the amount being spent by Canada. It is interesting to note that only 15.9% of dollars spent is associated with the actual hands on care administered by the doctor to the patient.3 Yet ongoing efforts to reduce overall costs are primarily focused at lowering reimbursement to hospitals and physicians, all while administrative work continues to increase, i.e. billing, contract negotiation and increasing requirements associated with quality care outcome measure submission and documentation.
Although most would agree that universal healthcare is critically needed, any plan that is to be successful in achieving this goal must first focus on preserving the primary resources utilized in its provision (the physician) while eliminating unnecessary costs associated with profit and administrative costs. This paper will examine the real cost associated with physician salaries, why Medicare for All is not a viable economic solution for the country as a whole or for physicians, and offer ideas and methods already being utilized in successful, developed countries around the world with the goal of creating a universal healthcare plan that can economically and sustainably support everyone.
Real Cost Comparison- Physicians vs. Other Professionals
Although most physicians don’t enter the profession for the money, altruism is inconsistent with economic rationality. People typically behave altruistically because they get some benefit, or utility, from doing so.4 Very few would consider investing staggering amounts of money, energy, and time in order to become a physician who works for free or even a marginal return. In order for the supply of the resource (in this case the physician) to remain sufficient to meet the demands of the healthcare system, the basic rule of rational economic decision-making applies. The marginal utility received (revenue, satisfaction, lifestyle, etc.) from delivering these services must exceed the marginal cost of becoming and remaining a physician. 5
Physicians are considered one of the highest paid professions coming in closely behind investment bankers and entrepreneurs. But like investment bankers this appearance can be grossly misleading. When factoring in the “real cost” associated with becoming a physician; coupled with the utility (revenue and job satisfaction) returned, a very different picture emerges. Real costs include the exertions of all the different kinds of labor that are directly or indirectly involved in making it, together with the time required waiting for saving the capital used in making it.6 This includes the direct cost of education, the lost opportunity costs associated with the time spent in medical school and residency without offsetting revenue, non reimbursed labor costs associated with educational training coupled with reimbursed labor by the hour as a physician who typically expends quite a bit more than a 40 hour work week.
Breaking these costs down into an easy to understand wage per hour summary will give a better understanding of earnings of physicians as compared to other professionals. Multiple studies exist attempting to compare actual realized physician earned dollars/hour with other professions. One wildly liberal comparison showed physicians making about 0.03 cents more per hour then teachers when all factors were considered.7 Although this study was fundamentally flawed due to its vast overestimation of total number of hours worked over a lifetime, it does bring attention and focus to the simple fundamental truth that physicians invest large sums of money, and return considerably more labor than the standard 40 hour week while sacrificing vast opportunity costs before earning a cent. Physicians don’t typically work according to a time clock. Working weekends, and nights and holidays is a common occurrence and many of these hours are not reimbursable as they are spent performing administrative duties, traveling to multiple sites, or simply waiting on procedures or patients to be transferred to the operating room.
The following is a realistic comparison of two professionals’ salaries and average wage/hour estimates projected over a lifetime with retirement set at 65 years of age. Tom and Mary are the same age. Tom decides to become a physician anesthesiologist and Mary chooses to become a nurse. They both begin school at the same time and each will have 43 years to work toward their lifetime-realized income.
They both attend undergraduate school together and each receives Bachelor of Science degrees in chemistry and nursing respectively. Since they both have equitable college loans from undergraduate studies, the comparison will begin as their paths diverge. For ease of comparison, no adjustments have been made to these numbers for cost of living or taxes withheld for either party.
Following graduation, Mary works as a registered nurse and averages 40 hours a week. The Bureau of Labor Statistics states she will be paid a yearly mean salary of $75,510.00 for 2,080 hours of work /year.8 Upon Mary’s 65 birthday she will have accumulated a lifetime total of 89,440 hours worked and a gross lifetime wage earnings of $3,246,930.00 which equates to an average hourly wage of $36.30.